ACTRN12606000507583已完成2 期
A Randomized Phase 2 Trial of Double-Blind, Placebo Controlled AMG 706 in Combination with Paclitaxel, or Open-Label Bevacizumab in Combination with Paclitaxel, as First Line Therapy in Women with HER2 Negative Locally Recurrent or Metastatic Breast Cancer
Amgen Inc.0 个研究点目标入组 273 人开始时间: 2006年12月7日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 273
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 ot stated（—）
- 性别
- Female
入选标准
- •Confirmed HER2 negative locally recurrent or metastatic breast cancer (locally recurrent disease must not be amenable to resection with curative intent); measurable disease per RECIST (Response Evaluation Criteria in Solid Tumor) guidelines; complete radiology and tumor measurement within 4 weeks (28 days) prior to randomization; ECOG Performance Status of 0 or 1; adequate organ and hematological function; negative pregnancy test within 7 days prior registration for patients of child-bearing potential and sexually active; written informed consent signed prior to any study-related procedures.
排除标准
- •1. Adjuvant or neoadjuvant taxane treatment within 12 months of randomization. Any other adjuvant chemotherapy regimen must be discontinued at least 3 weeks (21 days) prior to study randomisation.2. Prior chemotherapy for locally recurrent or metastatic breast cancer (prior endocrine therapyis permitted).3. Prior radiation therapy, radiofrequency ablation, percutaneous cryotherapy or hepaticchemoembolization on all sites of measurable disease unless disease progression was subsequently documented on at least one of these sites.4. Current or prior history of central nervous system metastasis.5. Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 peripheral neuropathy > grade 2 at registration.6. Average systolic blood pressure > 145 mm Hg or average diastolic blood pressure > 85 mm Hg (average blood pressure of the 3 separate blood pressure values measured according to the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure).7. History of arterial or venous thrombosis within 1 year prior to randomisation.8. History of bleeding diathesis or bleeding within 14 days of randomisation.9. Major surgical procedure within 4 weeks (28 days) prior to randomisation.10. Minor surgical procedure, placement of access device, or fine needle aspiration within 7 days of randomisation.11. Known positive test for human immunodeficiency virus (HIV), hepatitis C, or malignancy (other than in situ cervical cancer, or basal cell cancer of the skin), unless treated with curative intent and without evidence of disease for = 3 years before study randomisation.12. Clinically significant cardiac disease within 12 months of study randomisation, including myocardial infarction, unstable angina, grade II or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or ongoing arrhythmias requiring medication or pacemaker.13. Non-healing wound, ulcer or fracture.14. Ongoing or active infection.15. Positive hepatitis B surface antigen.16. Known chronic hepatitis.
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